Cleared Traditional

Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant, (K192204) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192204 · Valencia Naturals, Inc. · Obstetrics & Gynecology device
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Nov 2019
Decision
97d
Days
Class 2
Risk

K192204 is an FDA 510(k) clearance for the Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant.... Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Valencia Naturals, Inc. (Chatsworth, US). The FDA issued a Cleared decision on November 19, 2019 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Valencia Naturals, Inc. devices

Submission Details

510(k) Number K192204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2019
Decision Date November 19, 2019
Days to Decision 97 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 160d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NUC Lubricant, Personal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
Definition This Device Is A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Intimate Sexual Activity, And Supplement The Body's Natural Lubrication. This Product May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Med-Device Consulting, Inc.
Louie Goryoka

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NUC Lubricant, Personal

All 116
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K192204.
Ah!Yes Ob Coco Personal Lubricant
K191411 · Bio-Tech Lubricants, Ltd. · Feb 2020
HyaloGYN Vaginal Moisturizing Suppositories
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Satisfaite
K190752 · Femmepharma Consumer Healthcare, LLC · Dec 2019
Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)
K191480 · Trigg Laboratories, Inc. D/B/A Wet International · Oct 2019
Aloe Glide Lubricant
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Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant
K190858 · United Consortium · Sep 2019